Rezolute, Inc. (Nasdaq: RZLT) has announced significant progress in its clinical programs and financial results for the fourth quarter and full fiscal year 2024, ending June 30, 2024. The company is focused on developing therapies for rare diseases, particularly those addressing hypoglycemia caused by hyperinsulinism (HI).
Ersodetug Advances to Phase 3 for Congenital and Tumor HI
The U.S. Food and Drug Administration (FDA) has lifted the partial clinical holds on ersodetug, Rezolute's investigational drug for congenital HI. This decision allows the Phase 3 sunRIZE study to proceed in the U.S., with patient enrollment expected to begin in early 2025. Topline results from the sunRIZE study are anticipated in the second half of 2025.
Ersodetug, a fully human monoclonal antibody, targets a unique allosteric site on insulin receptors. This mechanism counteracts the over-activation of insulin receptors by insulin and related substances, such as IGF-2, thereby mitigating hypoglycemia in HI patients. Its action downstream from the pancreas makes it potentially effective across various forms of HI.
In addition to congenital HI, the FDA has cleared the Investigational New Drug (IND) application for a Phase 3 registrational study of ersodetug in tumor HI. This study is scheduled to begin in the first half of 2025, primarily in the U.S., with topline results expected in the second half of 2026. Several insulinoma patients have already been treated with ersodetug under the Expanded Access Program (EAP).
Positive Phase 2 Results for RZ402 in Diabetic Macular Edema
Rezolute also reported positive topline results from its Phase 2 proof-of-concept study of RZ402 in patients with diabetic macular edema (DME). The study met its primary endpoints, demonstrating good safety and tolerability. A significant reduction in central subfield thickness (CST) was observed in the study eye at all RZ402 dose levels compared to placebo, with improvements of up to approximately 50 microns.
The company is currently seeking potential partners to further develop RZ402.
Financial Highlights
As of June 30, 2024, Rezolute's cash, cash equivalents, and investments in marketable securities totaled $127.1 million, compared to $118.4 million on June 30, 2023.
Research and development (R&D) expenses for the fourth quarter of fiscal 2024 were $19.1 million, compared to $10.9 million for the same period last year. Full fiscal year 2024 R&D expenses totaled $55.7 million, up from $43.8 million in fiscal year 2023. This increase is primarily attributed to higher expenditures in clinical trial activities, manufacturing costs for ersodetug, milestone payments to license agreement partners, and increased employee-related expenses.
General and administrative (G&A) expenses for the fourth quarter of fiscal 2024 were $4.0 million, compared to $3.3 million for the same period a year ago. Full fiscal year 2024 G&A expenses were $14.7 million, compared to $12.2 million in fiscal year 2023. The increase was primarily due to employee-related expenses and professional fees.
Rezolute reported a net loss of $23.0 million for the fourth quarter of fiscal 2024, compared to a net loss of $12.7 million for the same period last year. The full fiscal year 2024 net loss was $68.5 million, compared to a net loss of $51.8 million for fiscal year 2023.
Management Commentary
"We are thrilled to close out the year with FDA alignment to advance ersodetug in two Phase 3 rare disease programs for the treatment of hypoglycemia resulting from congenital and acquired forms of hyperinsulinism," said Nevan Elam, Chief Executive Officer and Founder of Rezolute. "The Phase 3 sunRIZE study remains on track for ex-U.S. participant enrollment and we expect U.S. enrollment to begin in the first part of 2025. We look forward to progressing both Phase 3 studies and remain excited at the prospect of ersodetug as a best-in-class treatment for hyperinsulinism based on the success we’ve seen to date."
